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FTC Staff’s Two Clinical Trials Standard Likely to Continue Even if POM Wins

In the POM Wonderful case, the FTC ALJ rejected FTC staff demands that certain claims there in issue had to be backed by at least two well-designed clinical trials or they would be deemed deceptive.  The issue is before the full Commission and will be decided on January 18, 2013.  Even if the full Commission upholds the ALJ’s decision on this point, the FTC staff will likely still require this same degree of evidence in support of certain claims, albeit through indirection.  The staff will likely deem lesser evidence inadequate on one subjective ground or another without specifically referencing a demand for two clinical trials.  Consequently, the industry is well advised to adhere to the two clinical trial standard as a minimum threshold even if the full Commission rejects the staff’s arguments on appeal.

The FTC has long required that advertisers have a “reasonable basis” for making an objective claim before disseminating the claim?  Pfizer Inc., 81 F.T.C. 23, 86 (1972); Policy Statement Regarding Advertising Substantiation Program, appended to Thompson Med. Co., 104 F.T.C. 648, 839-840 (1984), aff’d 791 F.2d 189 (D.C. Cir. 1985).

What is a “reasonable basis” exactly?  When claims concern health, safety, and/or product efficacy, such as structure/function claims for a dietary supplement, FTC says a “reasonable basis” means “competent and reliable scientific evidence” which has been defined as “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”  See, e.g., Novartis Corp., 127 F.T.C. 580, 725 (1999); see also In Re Schering Corp., 118 F.T.C. 1030, 1123 (1994).  The definition gives FTC extraordinary discretion in an area directly regulating speech.  Such discretion has been held unconstitutional in other contexts, such as when a state board endeavors to prohibit obscene or indecent movies.  See, e.g., Freedman v. State of Md., 380 U.S. 51, 85 S. Ct. 734, 13 L. Ed. 2d 649 (1965).  Peculiarly, federal agencies are allowed this degree of discretion.  See, e.g., 27 U.S.C. § 205(e) (authorizing the prevention of false, misleading, obscene, or indecent statements in advertisements of distilled spirits, wine, or malt beverages).

Under its “competent and reliable scientific evidence” substantiation standard, FTC acknowledges that different types of claims require differing levels of evidence, and it defers to experts in the field for that answer.  The standard is intentionally subjective, giving the agency discretion to determine on a case-by-case basis whether claims are adequately substantiated.  “The FTC gives great weight to accepted norms in the relevant fields of research and consults with experts from a wide variety of disciplines.”  FTC, Bureau of Consumer Protection, Dietary Supplements: An Advertising Guide for Industry (1998).  That subjectivity yields endless conflicts with the regulated class because regulatees often believe they are groping in the dark for answers.  They ask, will FTC second guess my clinical study?  Will FTC require more studies?  Will FTC accept a plethora of case control studies or epidemiological studies to support my claim?

FTC recurs to the point that the relevant question is whether experts in industry and health sciences regard the proffered evidence yields accurate and reliable results.  Thus, FTC examines both the methodology and the results.  A qualitative showing is necessary on both elements.  Nevertheless, experts rarely, if ever, agree, and some will proclaim a study iron clad and dispositive of a health benefit, while others will challenge the methods in the supporting science or proffer hypotheses as to confounding factors that may have influenced outcomes.

Because the “competent and reliable scientific evidence” standard is so flexible, FTC and FDA have previously said there is no fixed protocol concerning the types of studies needed, how many studies are needed, or how many test subjects are necessary.  Like with the government’s perception of obscenity, FTC and FDA simply proclaim that they know it when they see it, and they offer no formal advisory opinions on the adequacy of scientific support.

In our experience, whenever the FTC challenges a claim, they invariably demand from the advertiser near conclusive proof of a claim’s validity, i.e., well-designed, randomized, prospective, double-blind, placebo-controlled clinical trials in support of each claim.  They often pick apart even clinical trial data if their subjective bias against the claim confronts clinical trial evidence for it.

In July 2010, FTC entered into consent orders with two companies requiring them to support future weight loss claims and claims that a product reduces the duration of acute diarrhea in children up to the age of thirteen or reduces absences from daycare or school due to illness with competent and reliable scientific evidence consisting of at least two adequate and well-controlled human clinical studies of the product, or of an essentially equivalent product, conducted by different researchers, independently of each other, that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that these representations were true.  See FTC v. Iovate Health Sciences USA, Inc., Case. No. 10-CV-587 (W.D.N.Y. July 29, 2010) (Stipulated Final Judgment), available at (last accessed Dec. 3, 2012); Nestlé HealthCare Nutrition, Inc., FTC File No. 092-3087, Agreement Containing Consent Order (July 14, 2010), available at 100714nestleorder.pdf (last accessed Dec. 3, 2012).

Although FTC has not explicitly repudiated its Dietary Supplements: An Advertising Guide for Industry, which states that “FTC will consider all forms of competent and reliable scientific research when evaluating substantiation,” including animal and in vitro studies “particularly where they are widely considered to be acceptable substitutes for human research or where human research is infeasible,” and that the “quality of studies will be more important than quantity,” the agency has tried to apply the heightened substantiation requirements announced in the Iovate and Nestlé consent orders to advertisers not subject to those consent orders.  Specifically, in the recent POM Wonderful decision, FTC argued that multiple clinical trials were always required for certain health benefit claims.  FTC lost on that issue before an administrative law judge but an appeal is pending, and, certainly, FTC continues to favor the multiple clinical trial standard it attempted to foist upon the industry despite the ALJ’s decision.   A final administrative decision and order is expected to be released on January 18, 2013.

FTC seems poised to assert that all health benefit claims require at least two clinical trials for substantiation.  Whether FTC will be successful remains to be seen, but if it is, the two clinical trial requirement could take effect in a little over a month from now.   Even if the staff loses before the full Commission, it is possible that the staff will effectively circumvent the decision by challenging the adequacy of evidence case by case until the two clinical trial threshold is met.  In other words, rather than overtly demanding the two clinical trials, the staff could consistently reject evidence less than that on one or more subjective grounds, thus creating a de facto two clinical trial standard over time.

The two clinical trial requirement ignores the fact that human clinical trials are not practical for all claims.   Nonetheless, the prudent advertiser mindful of this administration’s bias in favor of greater scientific evidence supportive of claims should strive to attain the two clinical trials in support standard whenever feasible.  That is particularly true in light of the Office of Inspector General’s October 2012 report entitled, “Dietary Supplements: Structure/function Claims Fail to Meet Federal Requirements,” which indicated that claim substantiation will likely be a big issue in the near future.  The OIG report found that the substantiation behind weight loss and immune system support structure/function claims of sampled dietary supplements were inconsistent with the competent and reliable scientific evidence standard.

Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.

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